FDA Device

Product is SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3.

Hazard

In the creation of revised report and supplemental reports diagnosis, text was inserted from another case.

What You Should Do

Remedy

Consignees were notified of recall and provided with a software correction patch ICC number 3618.

Products

Product is SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3.
Brand
SCC Soft Computer
UPC
Version 1.2, 2.1, 2.2 and 2.3

Units Affected

201